Device for testing for the presence of micro-organisms

ABSTRACT

A device to test for the presence of micro-organisms, comprising a culture medium for promoting the growth of micro-organisms, and a carrier carrying the culture medium and having with the latter a configuration and size enabling a carrier and culture medium carried thereby to be comfortably introduced into a body cavity and temporarily retained therein with the culture medium being exposed by a carrier to the presence of micro-organisms which are suspected in the body cavity.

States Patet Bucalo Dec. 9, 1975 [5 DEVICE FOR TESTING FOR THE 3,368,5492/1968 Barr et a1. 128/2 w PRESENCE OF MICRO-ORGANISMS 2 233 225 2/'lljlniiliarrn}.1 11298502];

, 0 ant et a Inventor: Louis Bucalo, 155 rts t, 3,817,839 6/1974 Warren195/139 x Holbrook, N.Y. R24,666 7/1959 Draghi 128/2 W [22] Filed: Aug.23, 1974 FOREIGN PATENTS OR APPLICATIONS [21] Appl. No.1 499,926 349,8856/1931 United Kingdom 128/270 Related Application Data PrimaryExaminer-Kyle L. I-Iowell [62] l3)i8vis2ion of Ser. No. 329,862, Feb. 5,1973, Pat. No. Attorney, Agent, or Firm-Steinberg & Blake 57 ABST CT[52] US. Cl 128/2 W; 128/270; 195/139; RA

evlce 0 es or e presence 0 m1cro-0r amsms, 51 1111. c1. A61B 10/00comprsmg Culture. medum for P [58] Field 61 Search 128/2 w, 2 B, 269,270; growth of P a Came carrymg culture medium and havmg w1th the lattera configura- 195/139, 140, 424/9 t10n and s1ze enabhng a carr1er andculture medlum [56] References Cited gagied thterebyc/l to be COIIiIfOI'IiibIy (ijntgoduced irlrltclzha 0 y cavl y an emporan y retame terem wit e UNITED STATES PATENTS culture medium being exposed by acarrier to the "l --t--l presence of micro-organisms which are suspectedin p1e erg e a. 2,301,868 11/1942 Gurley, Jr. et al 128/270 X the bodycavity. 3,282,114 1 H1966 Pell 128/2 W 8 Claims, 5 Drawing Figures US.Patent Dec. 9, 1975 3,924,607

CROSS-REFERENCE TO RELATED APPLICATION This application is a division ofcopending application Ser. No. 329,862, filed Feb. 5, 1973, and entitledMethod and Device for Testing for the Presence of Micro-Organisms, nowUS. Pat. No. 3,842,166.

BACKGROUND OF THE INVENTION The present invention relates to devices fortesting for the presence of micro-organisms.

At the present time, in order to determine whether or not a patientsuffers from certain maladies, a physician will take a swab and apply itto an area of the body where the present of micro-organisms issuspected, removing a smear from the suspected area and applying it to aculture medium which is then incubated in a suitable incubator for aperiod of time so as to determine whether or not the suspectedmicro-organisms are indeed present. Thus, the physician will apply theswab to the ear, nose, throat, vagina, or the like, and will then applya smear to the culture medium which is normally supported in a suitabledish. After the smear is applied to the surface of the culture medium,the dish with the medium is placed in the incubator, and after a givenincubation period at a predetermined temperature the culture medium isinspected to determine whether or not there has been a growth of thesuspected microorganisms.

Thus, with the above conventional procedures it is essential to carryout the steps of applying the swab to the area which is suspect,transferring a smear to the culture medium, and an incubator is requiredto receive the culture medium. I

These procedures are relatively involved, create a certain amount ofdiscomfort to the patient, and require the use of equipment such as anincubator. Very often a physician does not have an incubator availablefor his own use and must send the swab with the smear thereon to alaboratory where the incubation is carried out. The laboratory will theninform the physician of the result of the incubation.

In addition to the disadvantages resulting from the time andinconvenience as well as the equipment required for the aboveconventional procedures, there is always the possibility that anincorrect diagnosis is made. For example, it may happen that themicroorganisms are thriving in the body of a patient, whereas in thetransfer of the smear to the culture medium and in the incubationthereof the conditions for growth of the micro-organisms are differentfrom that which prevails in the body, so that even though a negativeresult is indicated after incubation, nevertheless micro-organ isms maystill be present unknown to the physician because the conditions forgrowth in the incubator are not the same as in the body and improperdiagnosis results. Moreover, because of the delay encountered with theabove procedures it often is not possible to treat a patient as soon asdesirable. The result is that for safety purposes patients willsometimes be treated for diseases which they actually do not have.

SUMMARY OF THE INVENTION It is accordingly a primary object of thepresent invention to provide a device which will avoid the abovedrawbacks.

In particular, it is an object of the invention to provide a devicewhich will eliminate the need for an incubator.

In addition, it is an object of the present invention to provide adevice which will eliminate the necessity for transferring with a swab asmear from a suspected area of a patient to a culture medium.

Furthermore, it is an object of the present invention to provide anapparatus which will enable the presence of micro-organisms to bedetected under the very same conditions as those prevailing in the bodyof a patient.

In addition, it is an object of the present invention to provide adevice which will enable tests for the presence of micro-organisms to becarried out in a simple, inexpensive, highly convenient manner directlyby an attending physician without requiring the use of the facilities ofa laboratory. Thus, it becomes possible with the present invention toavoid any delays such as those involved in mailing specimens to alaboratory to test it.

According to the invention a culture medium is introduced directly intoa body cavity where it is suspected that micro-organisms may be present.This culture medium is permitted to remain in the body cavity for aperiod of time which is sufficient to indicate growth of themicro-organisms if indeed they are present. After this latter period oftime has elapsed the culture medium is removed from the body cavity andexamined so that an accurate diagnosis can be conveniently made in asshort a time as possible.

The device of the invention includes a culture medium which is carriedby a carrier means which together with the culture medium has a size andconfiguration enabling the device to be comfortably and convenientlyintroduced into a body cavity to remain temporarily therein for the timerequired for the microorganisms, if any, to grow at the culture medium,so that after removal of the device it can be examined to make anaccurate diagnosis.

BRIEF DESCRIPTION OF DRAWINGS The invention is illustrated by way ofexample in the accompanying drawings which form part of this applicationand in which:

FIG. 1 is a schematic illustration of a device of the invention situatedin a body cavity;

FIG. 2 is a sectional elevation, on an enlarged scale as compared toFIG. 1, of the device of FIG. 1 taken along line 22 of FIG. 1 in thedirection of the arrows;

FIG. 3 is an elevation of another possible embodiment of a deviceaccording to the invention;

FIG. 4 is a sectional plan view of the device of FIG. 3 taken along line4-4 of FIG. 3 in the direction of the arrows; and

FIG. 5 is a schematic representation of the manner in which the deviceof the invention may be incorporated into a tampon.

DESCRIPTION OF PREFERRED EMBODIMENTS In accordance with the presentinvention, instead of obtaining a smear from a part of the body where itis suspected that micro-organisms are present and placing the smear on aculture medium which is then incubated, the culture medium is placeddirectly in the body cavity at the area where the presence of themicro-organisms is suspected, and after a time normally required forgrowth of the micro-organisms, if any, the device of the invention isremoved from the body cavity and examined so as to diagnose whether ornot there are indeed micro-organisms present at the body cavity. In thisway it becomes unnecessary to use incubators, to transfer a smear to aculture medium, and the diagnosis is made as rapidly as possible and asaccurately as possible since the growth of the micro-organisms, if any,takes place directly in the body under precisely the same conditionswhich prevail in the body of the patient.

Thus, referring to FIG. 1, there is schematically illustrated therein apart of the body of a human being, this part 10 having the body cavity12. This schematically illustrated body cavity 12 may be any cavity ofthe body such as the mouth, the nose, a sinus passage, the ear, the analcanal, the vagina, the urethra, the uterus, etc.

Assuming that a physician suspects a given area of the body as beinginfected by a micro-organism, the physician will simply introduce intothe body cavity where the presence of infection is suspected a device 14according to the present invention. This device 14 includes a culturemedium 16 (FIG. 2) which may be any known culture medium which willpromote the growth of micro-organisms if the latter are present. Sincesuch culture mediums normally are not capable of retaining a given shapeand size, the culture medium 16 is carried by a carrier means whichincludes a body 18 of compressed filamentary material and an outer frame20 which carries the compressed body 18 of filamentary material. Thisbody of filamentary material 18 may be compressed cotton fibers, finegold wire filament, or any fine plastic monofilaments such as nylon orpolyester filaments which when compressed form a large surface areahaving a large number of interstices in which the nutrient or culturemedium 16 will be come located. The frame 20 forms a shell whichsurrounds the body of compressed filamentary material 18 to retain thelatter in its compressed condition. This frame 20 in the example of FIG.2 includes a pair of receptacles portions 20a and 2012 joined togetherat their mating flanges 22 and releasably held together for example bygluing these flanges to each other if desired. The walls of the shell20a and 20b are formed with a large number of openings 24 through whichthe microorganisms will have free access to the culture medium 16.

In the embodiment of FIGS. 3 and 4, in order to expose as large an areaas possible of the culture medium, the compressed body 18 of filamentarymaterial which supports and carries directly the culture medium issituated within and surrounded by a frame 26 made up of a number ofintersecting ribs 28 which provide the relatively large open spacesindicated in FIGS. 3 and 4 so that the culture medium is almost entirelyexposed at the outer surface of the compressed body of filamentarymaterial 18.

According to the embodiment of FIG. 5, which is particularly adapted foruse in testing for gonorrhea or vaginitis, the device of the inventionsuch as that of FIG. 2 or that of FIG. 3 is incorporated into a tampon30 of the type which is normally inserted into the vagina during themenstrual cycle, this tampon 30 having the string 32 which enables it tobe conveniently removed. Thus, FIG. 5 shows a pair of the devices 14incorporated into the tampon 30 which may then be convenientlyintroduced into the vagina to remain therein for a period of timesufficient to permit micro-organisms if they are present to grow at theculture medium in the devices 14. Then the tampon 30 is removed and thephysician may examine the devices 14 to determine whether or notmicro-organisms are present. I

With respect to the devices of FIGS. 2 and 3, the outer frame such asthe frame 20 of FIG. 2 or the frame 26 of FIG. 3 may be made of anymetal or plastic compatible with the human body. The compressed body offilamentary material may be made of any of the filamentary materialsreferred to above or combinations thereof, or in fact any filamentarymaterial compatible with the human body.

Examples of suitable culture mediums are as follows:

EXAMPLE 1 The following constitutes a diagnostic medium for determiningthe presence of Candida albicans in vaginal infection. This basic mediumis made antibacterial by the addition thereto of neomycin sulfate.

A medium is made of the following composition:

Yeast extract (H /k Glycine 1.071 Dextrose 1.0'71 Bismuth SulfiteIndicator 0.871

Neomycin Sulfate 0.000292 Agar 2.09? Water q.s. I00.(W1

When C. Albicans is present black colonies appear, while any otherfungus will not give this type of growth. Bacteria are inhibited by boththe Neomycin Sulfate and Bismuth Sulfite lndicator.

EXAMPLE 2 For identifying Alpha and Beta Hemolytic Streptococci andStephylococci.

Beef Heart Infusion 500 gm. Tryptose l0 gm. Sodium Chloride 5 gm. Agar20 gm. Water, q.s. I000 ml.

EXAMPLE 3 For detecting bacterial growth in urine:

EXAMPLE 5 For identifying Proteus:

Thus, with any suitable culture medium, such as those in the examplesabove, it is possible for the physician utilizing the device of thepresent invention, simply to introduce the device directly into the bodycavity where it is suspected that the microorganisms are present. Thedevice is permitted to remain in the body cavity for the period of timerequired for growth of the micro-organism, if indeed it is present, andthereafter the physician will remove the device of the invention andwill examine it so as to determine whether or not micro-organisms areindeed present. Since the device of the invention is incorporateddirectly into the body cavity to remain there at body temperature andunder the exact conditions prevailing in the body, ideal conditions forgrowth of micro-organisms, if they are present, are used, and thus a farmore accurate diagnosis is possible with the present invention than withconventional techniques and apparatus. In addition, any physician canreadily practice the method of the invention without requiring the useof special equipment, laboratories, or the like, so that not only isthere a great convenience and high accuracy in the diagnosis, but inaddition there is a minimum of delay in making the diag- I nosis.

In any of the above devices, the culture medium may be divided intoseveral sections for indicating, respectively, the presence of differentmicro-organisms, so that a broad spectrum type of differential devicesis utilized for simultaneously growing a number of different cultures.For example, in FIGS. 2 and 3, the upper half of the illustrated devicesmay have a culture medium of one composition while the lower half mayhave a culture medium of a different composition so that in this way thedevices may be used to test for the presence of differentmicro-organisms which will respectively grow in the culture mediums ofdifferent compositions. Also, in the case of the tampon, the devicesincorporated therein may have, respectively, different culture mediumsfor indicating the presence of different microorganisms.

What is claimed is:

l. A device to test for the presence of microorganisms, comprising aculture medium for promoting the growth of micro-organisms which may bepresent in a body cavity such as the mouth, the nose, a sinus passage,the ear, the anal canal, the vagina, the urethra, the uterus, etc., ofthe type encountered in human be ings, and carrier means carrying theculture medium and forming with the latter a complete unit having at itsentire exterior surface a sufficient smoothness and a configuration andsize to be comfortably received in and temporarily retained and enclosedentirely within the body cavity with the culture medium being renderedaccessible by the carrier means to micro-organisms which are in the bodycavity, so that the microorganisms, if the are present in the bodycavity, can grow in the culture medium under the conditions whichprevail in the body cavity.

2. The combination of claim 1 and wherein said carrier means includes acompressed body of filamentary material surrounded by the culture mediumand having the latter situated in interstices within the compressed bodyof filamentary material, and said carrier means further including anouter frame surrounding and holding the compressed body of filamentarymaterial and the culture medium and formed with openings through whichmicro-organisms will have free access to the culture medium.

3. The combination of claim 2 and wherein the body of filamentarymaterial is composed at least in part of gold wire.

4. The combination of claim 2 and wherein the filamentary material iscomposed at least in part of cotton.

5. The combination of claim 2 and wherein said outer frame is in theform of a wall formed with a plurality of openings through which theculture medium is freely accessible.

6. The combination of claim 2 and wherein said outer frame is in theform of a network of intersecting ribs which define between themselvesspaces through which micro-organisms will have free access to theculture medium.

7. The combination of claim 1 and wherein the cul' ture medium isdivided into several sections respectively having different compositionsfor respectively indicating the presence of different micro-organisms.

8. A device to test for the presence of micro-organisms, comprising aculture medium for promoting the growth of micro-organisms which may bepresent in a body cavity, and carrier means carrying the culture mediumand forming with the latter a complete unit having at its exteriorsurface a sufficient smoothness and a configuration and size to becomfortably received in and temporarily retained and enclosed entirelywithin the body cavity, with the culture medium being renderedaccessible by the carrier means to micro-organisms which are in the bodycavity, so that the microorganisms, if they are present in the bodycavity, can grow in the culture medium under the conditions whichprevail in the body cavity, said carrier means including an outer frameformed with passage means through which micro-organisms have access tothe culture medium with said outer frame extending outwardly beyond theculture medium for substantially preventing direct contact between theculture medium and a surface which defines the body cavity.

1. A device to test for the presence of mIcro-organisms, comprising aculture medium for promoting the growth of microorganisms which may bepresent in a body cavity such as the mouth, the nose, a sinus passage,the ear, the anal canal, the vagina, the urethra, the uterus, etc., ofthe type encountered in human beings, and carrier means carrying theculture medium and forming with the latter a complete unit having at itsentire exterior surface a sufficient smoothness and a configuration andsize to be comfortably received in and temporarily retained and enclosedentirely within the body cavity with the culture medium being renderedaccessible by the carrier means to micro-organisms which are in the bodycavity, so that the micro-organisms, if the are present in the bodycavity, can grow in the culture medium under the conditions whichprevail in the body cavity.
 2. The combination of claim 1 and whereinsaid carrier means includes a compressed body of filamentary materialsurrounded by the culture medium and having the latter situated ininterstices within the compressed body of filamentary material, and saidcarrier means further including an outer frame surrounding and holdingthe compressed body of filamentary material and the culture medium andformed with openings through which micro-organisms will have free accessto the culture medium.
 3. The combination of claim 2 and wherein thebody of filamentary material is composed at least in part of gold wire.4. The combination of claim 2 and wherein the filamentary material iscomposed at least in part of cotton.
 5. The combination of claim 2 andwherein said outer frame is in the form of a wall formed with aplurality of openings through which the culture medium is freelyaccessible.
 6. The combination of claim 2 and wherein said outer frameis in the form of a network of intersecting ribs which define betweenthemselves spaces through which micro-organisms will have free access tothe culture medium.
 7. The combination of claim 1 and wherein theculture medium is divided into several sections respectively havingdifferent compositions for respectively indicating the presence ofdifferent micro-organisms.
 8. A device to test for the presence ofmicro-organisms, comprising a culture medium for promoting the growth ofmicro-organisms which may be present in a body cavity, and carrier meanscarrying the culture medium and forming with the latter a complete unithaving at its exterior surface a sufficient smoothness and aconfiguration and size to be comfortably received in and temporarilyretained and enclosed entirely within the body cavity, with the culturemedium being rendered accessible by the carrier means to micro-organismswhich are in the body cavity, so that the micro-organisms, if they arepresent in the body cavity, can grow in the culture medium under theconditions which prevail in the body cavity, said carrier meansincluding an outer frame formed with passage means through whichmicro-organisms have access to the culture medium with said outer frameextending outwardly beyond the culture medium for substantiallypreventing direct contact between the culture medium and a surface whichdefines the body cavity.